South Africa CCNFSDU Report 2003

Executive Summary and excerpt of section related to PROPOSED DRAFT GUIDELINES FOR VITAMIN AND MINERAL SUPPLEMENTS from the 2003 Codex session report prepared by Antoinette Booyzen of South African Codex Delegation for the Department of Health of her government.

EXECUTIVE SUMMARY

Attendance of the twenty-forth Session of the CCNFSDU
It was attended by 224 delegates, observers and advisors representing 48 member countries and 31 international organisations. Other African countries present were Egypt, Ghana, Kenya, Nigeria, and Uganda. The South African Delegation comprised Mrs A Booyzen, Assistant Director, Food Control and Mrs Anne Pringle representing the Health Products Association.

MATTERS REFERRED TO THE COMMITTEE BY THE COMMISSION AND OTHER CODEX COMMITTEES

1.1 The report of the FAO Technical Workshop on Energy Conversion Factors is available now. In the mean time South Africa will update the list of conversion factors in the new draft food labelling regulations according the report’s recommendations.
1.2 The FAO/WHO Expert Consultation on upper levels for Vitamins and Minerals is part of the FAO future programme of work, subject to availability of funds. This work is expected to be completed by end 2005.
1.3 Since the discussion on the definition on trans fatty acids did not conclude on a final definition, Malaysia offered to prepare a discussion paper for consideration at the next Session of the Committee. In the mean time the following definition will be used in South Africa for the purpose of nutrition information labelling: “Trans fat” means the trans fatty acids with non-conjugated double bonds (fully hydrogenated oils and partially hydrogenated oils); conjugated linoleic acid (naturally occurring in meat and dairy products) are excluded from this definition.

GUIDELINES FOR THE USE OF NUTRITION CLAIMS: DRAFT TABLE FOR NUTRIENT CONTENT CLAIMS: PART B: PROVISIONS ON DIETARY FIBRE (at step 7) and PROPOSALS FOR A DEFINITION, METHOD OF ANALYSIS AND CONDITIONS FOR DIETARY FIBRE CLAIM
A working group chaired by France was assigned with the task to consider the final conditions for fibre content claims as well as to come up with a definition for dietary fibre and a suitable method of analysis. Although discussed at length, no final conclusion could be reached and the working group, open to all members and observers will once again consider the definition suitable methods(s). A local working group will be convened by the Directorate: Food Control to assist with the compilation of meaningful comments.

DRAFT REVISED STANDARD FOR GLUTEN-FREE FOOD
The chairman of the Working Group on Prolamin Analysis and Toxicity (WGPAT), Prof Martin Stern introduced the new method, a reliable enzyme-linked immunoassay R5-Mendez (ELISA). The Committee accepted this new method and will now forward it to Committee on Methods of Sampling and Analysis (CCMAS) for endorsement. A level of 20 ppm as the condition for a claim “gluten free” is attainable and measurable.

PROPOSED DRAFT GUIDELINES FOR VITAMIN AND MINERAL SUPPLEMENTS
South Africa proposed new wording in the preamble because they are convinced of the healing properties of nutrients: “Most people who have access to a balanced diet can usually obtain all the nutrients they require from their normal diet to prevent deficiencies. Because foods contain many substances that promote health and prevent chronic diseases, people should therefore be encouraged to select a healthy diet and supplement this diet with those nutrients for which the intake from the diet is insufficient to meet the requirements necessary for the prevention of chronic diseases and/or for the promotion of health beyond the demands of preventing micronutrient deficiencies.” In the title of the WHO document “WHO Technical Report on Diet, Nutrition and the Prevention of Chronic Diseases” (2003) the WHO acknowledges the fact that nutrition plays a role in the prevention of chronic diseases. It was therefore the South African opinion that double standards are maintained by Codex if the CCNFSDU objects to the inclusion of the words “prevention of chronic diseases” in a Codex Guideline and Standard. It is incomprehensible how nutrition can be considered so inferior to medicine in keeping people healthy. The chairman clinged to an outdated Codex provision that states that only medicines may treat, heal or prevent illness, despite that fact that there is overwhelming evidence in reputable scientific literature proving that nutrition can heal and prevent diseases. South Africa intends to request the revision of the Section on prohibited claims in the Codex general Guidelines on Claims (CAC/GL 1-1979 (Rev. 1-1991) to be approved as new work at the next CCFL meeting, because foods and good nutrition can prevent, enhance, improve and in certain instances cure illness.
Maximum levels for vitamins and minerals should be based on nutrient appropriate scientific risk assessment where the only goal is safety. The implication of this decision is that it proves the Directorate: Food Control’s view all along that the current cut-off levels for vitamins and minerals as legislated under the Medicines and Related Substances Act, Act 101 of 1965 are completely unscientific and unjustified. The current list of NRV’s are incomplete and requires additions and updates. South Africa will chair the electronic working group and develop a document with proposals for revised NRV’s for consideration by the next session.

PROPOSED DRAFT REVISED STANDARD FOR INFANT FORMULA
One standard with one title and one preamble and two Sections (Section A which would cover formula for healthy infants and another Section B for formula for special medical purposes for infants) will be developed, and the scope for each section would than clarify precisely what would be covered by the specific Section The decision how to incorporate the standard into national law, e.g. one standards with sections or two separate standards would be left to national authorities. Only products which are suitable to satisfy by itself the nutritional requirements of an infant during the first months of life may be marketed as infant formula. It is an important breakthrough and is in line with new draft South African Regulations.

PROPOSED DRAFT REVISED STANDARD FOR CEREAL-BASED FOODS FOR INFANTS AND YOUNG CHILDREN
The document in general as it is at the moment corresponds well to the draft Infant foods Regulations proposed by South Africa. The document was advanced to Step 5.

PROPOSED DRAFT REVISION OF ADVISORY LISTS OF MINERAL SALTS AND VITAMIN COMPOUNDS FOR USE IN FOODS FOR INFANTS AND CHILDREN
The Draft Advisory List been revised by Germany and circulated for comments at step 3. For several compounds its was not possible to find appropriate references for purity requirements and it was also not clear enough where several compounds such as ferric phosphates presented under different headings were identical or not. Germany will revise the list based on written comments and comments made during the Session, the List will be circulated for comments at step 3 and consideration at the next Session.

PROPOSED DRAFT RECOMMENDATIONS ON THE SCIENTIFIC BASIS OF HEALTH CLAIMS
A working group under the leadership of France prepared a working document which was discussed during the meeting. The UK proposed to provide clear guidelines on the preparation of a dossier when approval for a health claim is submitted to the national authority, which can be included in the document. South Africa supported this since it would be most helpful for national authorities and the industry to have such guidelines. This document is expected to be of a great user value once it is finalized. France would update the document by taking comments received into account when preparing the document for consideration at next year’s Session.

DISCUSSION PAPER ON THE APPLICATION OF RISK ANALYSIS APPLIED TO THE WORK OF THE CCNFSDU
Australia prepared a paper on the application of risk analysis applied to the work of the CCNFSDU, and highlighted two recommendations in relation to the future work of the CCNFSDU in this area, namely: 1. To acknowledge that Working Principles for Risk Analysis are highly relevant to the Committee’s work; and 2. To elaborate specific principles and guidelines for Risk Analysis relevant to the work of the Committee. Risk Analysis Principles should acknowledge the unique characteristics of nutrients. Scientific process should be part of risk management decisions and that some guiding principles and guidelines were necessary especially for the establishment of safe upper levels of nutrients. There is a fundamental difference between risk assessment for chemicals and for nutrients; and an approach for nutrients should not be exclusively toxicological but should also be related to nutrition. There are no guidelines for risk assessment for nutrients, but that it would be useful to develop models and methods in this area, especially for the purpose of considering novel foods, and upper limits for nutrients. This should be addressed in future.

DATE AND PLACE OF THE NEXT SESSION
The next Session would take place in Bonn, Germany during the first week in November 2004.

RECOMMENDATIONS
11.1 That the Directorate: Food Control proceeds immediately with the publishing for comments of the new draft proposed regulations on Nutritional Supplements with new levels for Vitamins and Minerals;
11.2 That the delegation of South Africa, as chair of the electronic working group proceeds as soon as possible with the gathering and consolidating of information from interested member countries and observers on the updating of Nutrient Reference Values. A report has to be finalised by the end of July in order to give the secretariat enough time to circulate it to member countries for comments before the next Session of CCNFSDU (2004)
11.3 That South Africa will convene a local working group on dietary fibre to consider the issues raised during the meeting, in order to make meaning comments to next Session of the CCNFSDU.

4. PROPOSED DRAFT GUIDELINES FOR VITAMIN AND MINERAL SUPPLEMENTS

South Africa proposed the following new wording in the preamble:

“Most people who have access to a balanced diet can usually obtain all the nutrients they require from their normal diet to prevent deficiencies. Because foods contain many substances that promote health and prevent chronic diseases, people should therefore be encouraged to select a healthybalanced diet from food before considering any vitamin and mineral supplement and supplement this diet with those nutrients for which the intake from the diet is insufficient to meet the requirements necessary for the prevention of chronic diseases and/or for the promotion of health beyond the demands of preventing micronutrient deficiencies.” In cases where the intake from the diet is insufficient or where consumers consider their diet requires supplementation, vitamin and mineral supplements serve to supplement the daily diet

In the title of the WHO document “WHO Technical Report on Diet, Nutrition and the Prevention of Chronic Diseases” (2003) the WHO acknowledges the fact that nutrition plays a role in the prevention of chronic diseases. It was therefore the South African opinion that double standards are maintained by Codex if the CCNFSDU objects to the inclusion of the words “prevention of chronic diseases” in a Codex Guideline and Standard. The proposal was supported by the National Health Federation, a non-governmental organization representing consumers and by the Council for Responsible Nutrition, a USA-based supplements industry group. However, the EU representative denied this fact by saying that foods really have nothing to do with the prevention of disease!!. What immediately comes to mind is that European and global bureaucracy are dominated by other unspoken interests in matters of nutrition and health. The chairman responded by clinging to an outdated Codex provision that states that only medicines may treat, heal or prevent illness, despite that fact that there is overwhelming evidence in reputable scientific literature that nutrition can heal and prevent diseases. It is incomprehensible how nutrition can be considered so inferior to medicine in keeping people health, especially in a Committee such as the CCNFSDU who is supposed to have inputs by the best nutritional knowledge available in the world and who are suppose to protect consumer’s health, not the “disease business”. South Africa intends to request the revision of the Section on prohibited claims in the Codex general Guidelines on Claims (CAC/GL 1-1979 (Rev. 1-1991) to be approved as new work at the next CCFL meeting. Foods and good nutrition can prevent, enhance, improve and in certain instances cure illness.

As far as the determination of maximum levels for vitamins and minerals are concerned the Committee decided that the maximum levels should be based on nutrient appropriate scientific risk assessment where the only goal is safety. This approach is in line with Codex policies. The RDA approach was abandoned. This decision was the most important achievement of the whole meeting! The implication of this decision is that it proves the Directorate: Food Control’s view all along that the current cut-off levels for vitamins and minerals as legislated under the Medicines and Related Substances Act, Act 101 of 1965 are completely unscientific and unjustified.

Two other victories were unexpectedly achieved:
Both the following provisions which might have been potential loopholes for creating barriers to Trade were deleted to the delight of the South African delegation:
3.2.3 For vitamins and minerals with a narrow safety margin between the recommended daily intake and the adverse level, different maximum limits for the daily dose may be established at the national level. SA proposes to add the following at the end of the sentence: “… if the national authority can show scientifically that a level lower than that established by Codex is appropriate.” Our motivation: To stop regulatory authorities making unscientific barriers to trade.
5.9 All labels shall bear a statement that the supplement should be taken on the advice of a nutritionist, a dietitian or a medical doctor. South Africa also proposes to delete 5.9, since the product is safe as a food and therefore this type of statement is superfluous.

While considering Section 5.5 under Labelling the Chair recalled the need to update the NRV’s (Nutrient Reference Values) for labelling purposes. The current list of NRV’s are incomplete and requires additions and updates. South Africa indicated their willingness to chair the electronic working group (open to all interested delegations and observers) and to develop a document with proposals for revised NRV’s for consideration by the next session.

Since considerable progress has been made with the document it was agreed to advance the document to Step 5.

Antoinette Booyzen is Assistant Director of Food Control in the South Africa Department of Health. She is lead delegate for the South African delegation to the Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Uses.